Author: MRN
Every year we set ourselves new goals, both personally and professionally. For many in clinical research it is often the same goal year-in and year-out – how on earth do I:
- Manage to enroll enough patients for our study?
- Meet trial enrollment deadlines?
- Keep enrolled patients in our study?
So, how do we do this in 2025!? Well, as the saying goes – “New Year…. New Enrollment Methods!”
- Bring it back to the patient.
Patient-centricity is a buzzword that’s often thrown around, but what does it actually mean to the patient? In essence, it’s the concept that patients have been given a voice, ensuring that their needs are considered in both trial design and execution. And while no patient is identical in their needs, there will be common themes based on the type of disease they are battling, the targeted age group for the trial, and the patient’s ability to travel (even short distances) to and from the research site. Often these are all influencing factors and, regardless of the age group and the travel distance to site, they are all linked to a time or a financial burden, or both.When this is taken into consideration, patient-centricity in trial design becomes easier to understand. A patient-centric trial is one that is designed to allow patients to complete a portion of the required clinical visits at home or in their community. This then improves both enrollment and retention rates as the burden of taking part in the trial is somewhat, if not completely, alleviated.
- Understanding patient-centric solutions.
Patient-centric trials are those that adopt methodologies and technology that allow patients to take part in trials remotely. However, often this is often misconstrued as patients participating entirely through remote technology, such as wearables, telehealth devices and video calls. While technology plays an important role, hybrid trials or decentralized clinical trials (DCTs) most often rely on Healthcare Providers (HCPs) who visit the patients’ homes or community-based locations to conduct clinical care, which can include anything from investigative medicinal product (IMP) administration, blood draws, running a centrifuge, to the taking of vitals, completing questionnaires, and/or assisting with telehealth appointments.The goal of hybrid trials and DCTs is to allow patients to have some of their clinical visits take place either in their homes / convenient location, or in their community – only attending a clinical site for critical appointments. Few people live within a convenient distance from the closest clinical site and, even those that do, may not have the health or mobility to attend frequent appointments. By making trials more convenient, comfortable, and accessible, more patients will be likely to enroll in the study. Further, it will help ensure patient retention, as patients will have more opportunities to integrate the study into their daily lives.
However, it is not just patients that will benefit from hybrid trials and DCTs, but trial sites benefit too. A successful hybrid trial or DCT will not only help sites meet their study timeline targets through the increased enrollment and retention of patients, but it will also alleviate the burden of having to carry out those treatments and checks that can ultimately be done elsewhere.
For sites to successfully participate in hybrid trials and DCTs, they need to be supported and engaged with. It’s crucial for sites to understand how a hybrid/DCT model will help them meet their study timeline targets, as well as connect with them with the teams working in-home/community – allowing them to work in unison to achieve the same goals. By providing sites with resources and appropriate training on how the hybrid trial/DCT design will work, there will be more buy-in from the sites, and both the site and trial will be more successful.
- Design your trial around the patient – and support your sites.
Hybrid trials and DCTs have the highest chance of being successful and maximizing ROI when they are incorporated into trial designs, before the drafting of protocols. By building home and/or community support into the plan from the start, there are more opportunities to get site buy-in from the outset and maximize recruitment and retention strategies.By using solution providers to build patient-centric plans from the beginning, Sponsors will have access to expert knowledge that will allow for a tailored-approach to be taken to the trial design – customizing the solution(s) to meet the trial’s unique needs.
MRN has supported sites since 2006 by providing trial solutions, including home trials support (HTS) and Site Professional Support. In 2024 MRN extended this service and added more solutions to assist resource-constrained or research-naïve sites, connecting them to a global site network. In 2025, MRN continues to expand this network of sites that can bring more patient-centric trials to more patients, worldwide.
When studies can bring trials to patients’ homes and communities, it reduces the burden on them and their caregivers, and in-turn sites and sponsors save money as enrollment is accelerated, patient retention rates are high, and the study is completed on time. Ultimately, patient-centric trials are a win-win-win for sponsors, sites, and patients.